Morbid obesity is a major medical problem affecting millions of people. Many serious health problems are associated with morbid obesity, including hypertension, hyperlipidemia, exacerbation of diabetes mellitus, heart disease, degenerative arthritis, and Pickwickian syndrome, certain types of cancer, gallstones, varicose veins, thromboembolism and hernias. Additionally, morbid obesity can lead to psychosocial difficulties such as depression, loss of self-esteem and decreased employability.
Attempts to induce weight loss in morbidly obese patients have been largely unsuccessful. Diet, exercise and behavioral modification are usually not effective in the long term because the morbidly obese patient does not maintain adherence to these programs. Further, such programs may risk further damage to the patient's health. The long term use of pharmaceuticals in bariatric medicine is also problematic. Use of pharmaceutical agents may lead to addiction, undesired side effects, and/or loss of potency due to drug tolerance.
Surgical procedures that have been applied include jejunoileal or gastric bypass surgery, gastroplasty and gastric stapling and oral surgical procedures such as wiring shut the patient's jaws to reduce food intake. These procedures are effective in producing weight loss, but are invasive, with associated risks and recovery times, as well as being expensive and often ineffective over the long term.
Various intragastric inflatable balloon devices have been heretofore used. These devices occupy the stomach cavity, thereby reducing its volume, and providing satiety. Problems associated with these devices include undesired deflation, requiring surgical removal, and ulceration or necrosis created by constant pressure of the device on the stomach wall and gastric outlet obstruction.
Placement of devices by a percutaneous endoscopic gastrostomy (PEG) procedures, while less expensive than surgical procedures, are less precise. Balloon type intragastric catheters positioned by PEG procedures, as described in De Hoyos Garza, U.S. Pat. No. 6,454,785, may block only a portion of the stomach, or they may block entry to the stomach from the esophagus if the device is not precisely positioned.